Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

Vaping Clinical Trial

Official title:

A Single-center, Randomized, Controlled, Open-label, Cross-over Study in Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles of 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System, Compared to Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05383508
• Other study ID #: P4-PK-04-US
• Status: Completed
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: August 25, 2022

Study information

• Verified date: April 2024
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), will be evaluated to provide further insights on product evaluation, craving, liking, puffing topography. The study will be conducted with three periods and six sequences in a cross-over design. This study is exploratory and there is no pre-specified hypothesis to be tested.

Description:

The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six minutes ad libitum use period. In addition, pharmacodynamic effects (PD), including subjective effects and related behavioral assessments, as well as human puffing topography (HPT) will be evaluated, to provide further insights on P4M3 Gen 2.0 product acceptance and product use. Safety will be assessed throughout the study. The aim is to evaluate if P4M3 Gen 2.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for current adult smokers who would otherwise continue smoking cigarettes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 25, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject has signed the ICF and is able to understand the information provided in the ICF.
• Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
• Subject has smoked = 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission.
• Subject does not plan to quit smoking cigarettes or using other nicotine or tobacco containing products in the next 3 months.
• Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.

Exclusion Criteria:

• As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
• Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
• BMI < 18.5 kg/m2 or > 35.0 kg/m2.
• Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer), which has an impact on CYP2A6 activity.
• Subject has a positive serology test for HIV 1/2, Hepatitis B or Hepatitis C.
• Subject has a history of alcohol abuse that could interfere with the subject's participation in study.
• Subject has a positive urine drug test.
• Subject has a positive alcohol breath test.
• Subject has participated in another clinical study within 30 days prior to the Screening Visit.
• Subject is pregnant (does not have negative pregnancy tests at Screening Visit and at Admission) or is breastfeeding.
• For women of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.

Related Conditions & MeSH terms

• Nicotine
• Vaping

Intervention

Other:
• CA35
Nicotine concentration: 3.5 % e-liquid flavor: Tobacco
• CM35
Nicotine concentration: 3.5 % e-liquid flavor: Menthol
• Cig
Subjects' preferred brand of commercially available, regular or mentholated cigarettes

Locations

Country	Name	City	State
United States	High Point Clinical Trials Center (HPCTC)	High Point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Background-corrected Maximum Plasma Concentration [Cmax]	To measure Cmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.	T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
Primary	Background-corrected Time to the Maximum Concentration [Tmax]	To measure Tmax from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.	T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
Primary	Area Under the Background-corrected Concentration-time Curve From Start of Product Use to Time of Last Quantifiable Concentration and Extrapolated to Infinity.	To measure the area under the background-corrected concentration-time curve (AUC) from start of product use from 6 minutes ad libitum use for two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette and for subjects smoking cigarettes.	T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)
Primary	Maximum Ratio of Background-corrected Concentration Over Time	To measure the maximum ratio of background-corrected concentration over time, from T0 (excluded) to Tmax (included)	T0 = start of product use. From day 1 to day 3, blood was drawn 5 minutes prior to T0 (day 1 only), and then 1, 2, 4, 6, 8, 10, 12, 15, 30 minutes, 1, 2, 4, 10 and 24 hours after T0. (Note that sample taken 24 hours after T0 on day 1 and day 2 only.)